Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Introduction: In the United States (US), a legal framework for approving biosimilars was established via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). At the time of writing (September 2022), 38 biosimilars have been approved […]
Author byline as per print journal: Yuqi Li, BS Pharm; Shein-Chung Chow, PhD Abstract: A biosimilar product is a biological product which is highly similar to an existing reference product in structure and function and has no clinically meaningful difference in terms of safety, purity or potency. Under the Biologics Price Competition and Innovation Act of […]
Author byline as per print journal: Federico J Piñeiro, Pharm, MPH; Fernández Argüelles Rogelio Alberto, Pharm, PhD Introduction/Objective: To describe the chiral switch, an evergreening strategy used by AstraZeneca to position enantiopure esomeprazole as the new proton pump inhibitor market leader, displacing its predecessor omeprazole. Methodology: A four-stage systematic review which included: a preliminary review, bibliographic […]
Author byline as per print journal: Lyndsay Davies1, PhD; Katie Milligan1, BSc; Mark Corris1, BSc; Ian Clarke1; Paul Dwyer1, MSc; Sarah Elizabeth Lee2, PhD; Jolene Teraoka3, BSc; Jill Crouse-Zeineddini3, PhD; Jane Hippenmeyer4, PharmD Study Objectives: To investigate the quality and in-use stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in both concentrated multi-dose bags and following […]
Author byline as per print journal: Nishalini Harikrishnan1, BSc; Ka-Liong Tan2, DPhil; Kar Ming Yee3, BPharm; Alia Shaari Ahmad Shukri1, MSc; Nalla Ramana Reddy4, MBBS; Chuei Wuei Leong3, PhD Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120 […]
Author byline as per print journal: Pieter J Glerum1,2, MSc; Mert Hayta1,3, PharmD, MSc; David M Burger4, PharmD, PhD; Cees Neef5, PharmD, PhD; Marcel L Bouvy3, PharmD, PhD; Marc Maliepaard1,6, PhD Background: Drug switching describes switching between drug products with the same active substance. Drug switching occurs commonly in the Netherlands and mostly between generic drug […]
Author byline as per print journal: Mansour Somaily1, MD; Hana Alahmari1, MD; Wejdan Abbag2; Shahenda Yousif4, MD; Nawar Tayfour4, MD; Nouf Almushayt2; Saleh Alhusayni3, MD; Saeed Almajadiah4, MD Background: A biosimilar version of infliximab (CT-P13) was recently approved for use in Saudi Arabia. Clinical data support its use in the treatment of rheumatic disease, however, […]
Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Steven Simoens4, MSc, PhD; Amanj Kurdi1,5, BSc, PhD; Gisbert Selke6; John Yfantopoulos7, PhD; Andrew Hill8, PhD; Jolanta Gulbinovič9, MD, PhD; Antony P Martin10,11, MA, PhD1; Angela Timoney1,12, BPharm, PhD; Dzintars Gotham13, MBBS; Janet Wale14, PhD; Tomasz Bochenek15, PhD; Iva Selke Krulichova16, MSc, PhD; Eleonora Allocati17, […]
Author byline as per print journal: Marzieh Zargaran1, PharmD, PhD Candidate; Abdol Majid Cheraghali 2,3, PharmD, PhD; Fatemeh Soleymani1,2, PharmD, MPH, PhD; Rajabali Daroudi4, BSc, MSc, PhD; Ali Akbari Sari4, MD, PhD; Professor Shekoufeh Nikfar1,2, PharmD, MPH, PhD Background: Enacting national policies which empower the local production of medications is a promising way to improve […]
Author byline as per print journal: Hye-Na Kang1, PhD; Robin Thorpe2, PhD; Ivana Knezevic1, PhD; Daehyun Baek3, PhD; Parichard Chirachanakul4; Hui Ming Chua5; Dina Dalili6, PhD; Freddie Foo7, MSc; Kai Gao8, PhD; Suna Habahbeh9, PhD; Hugo Hamel10, PhD; Edwin Nkansah11, PhD; Maria Savkina12, PhD; Oleh Semeniuk13; Shraddha Srivastava14; João Tavares Neto15, PhD; Meenu Wadhwa16, PhD; […]
Author byline as per print journal: Kelly Canham1, BSc Hons; Claire Newcomb2, MSc Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders. Patients with these diseases may experience manual dexterity challenges. Autoinjectors may improve dose accuracy, treatment adherence and quality of life; and reduce injection-site reactions. Studies […]
Author byline as per print journal: Jolita Seckute1, PhD; Ingrid Castellanos2, PhD; Steven Bane1, PhD Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into intravenous bags, extended storage, and simulated infusion to enable advanced preparation and storage. Methods: Two lots of ABP 215 were diluted to high- (16.5 mg/mL) […]
